Recognizes that virtually all new users of tobacco products are under 18 – the minimum legal age to purchase these products. Many new users will become addicted before they are old enough to understand the risks and ultimately will die too young of tobacco-related diseases. The Tobacco Control Act seeks to, among other things, prevent and reduce tobacco use by these young people.

Recognizes that tobacco products are legal products available for adult use, prohibits false or misleading labeling and advertising for tobacco products and provides the tobacco industry with several mechanisms to submit an application to FDA for new products or tobacco products with modified risk claims.

Gives FDA enforcement authority as well as a broad set of sanctions for violations of the law, and directs FDA to contract with states to assist FDA with retailer inspections.

Note: This overview highlights some of the provisions of the Tobacco Control Act and is not intended to be a comprehensive guide or to reflect FDA’s interpretation of the Tobacco Control Act. For complete information, you must read the entire law. For your convenience, in the text below we provide the section number of the Tobacco Control Act and a link to the full text of the section.

Note: Among its many provisions, the Tobacco Control Act required FDA to reissue its 1996 final regulations aimed at restricting the sale and distribution of cigarette and smokeless tobacco products. (Section 102)The Tobacco Control Act specifically:

Prohibits “reduced harm” claims including “light,” “low,” or “mild,” without an FDA order to allow marketing – Sec. 911 of the Federal Food, Drug, and Cosmetic Act (FDCA)

Requires industry to submit marketing research documents – Sec. 904 of the FDCA

Requires bigger, more prominent warning labels for cigarettes and smokeless tobacco products. However, the implementation date is uncertain, due to ongoing proceedings in the case of R. J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, No, 11-1482 (D.D.C.), on appeal, No 11-5332 (D.C.Cir.).

Packaging and advertisements for cigarettes and smokeless tobacco must have revised warning labels with a larger font size. Font colors are limited to white on a black background or black on a white background. – Sec. 201 and 204

Cigarette package health warnings will be required to cover the top 50 percent of both the front and rear panels of the package, and the nine specific warning messages must be equally and randomly displayed and distributed in all areas of the United States. These messages must be accompanied by color graphics showing the negative health consequences of smoking cigarettes. – Sec. 201

Smokeless tobacco package warnings must cover 30 percent of the two principal display panels, and the four specific required messages must be equally and randomly displayed and distributed in all areas of the United States. – Sec. 204

Gives FDA authority over, among other things:

Registration and inspection of tobacco companies – Sec. 905 of the FDCA

– Requires owners and operators of tobacco companies to register annually and be subject to inspection every 2 years by FDA.

– The action plan details FDA’s current thinking on how it intends to enforce certain requirements under the Tobacco Control Act.

The Tobacco Control Act also requires

Tobacco industry must disclose research on the health, toxicological, behavioral, or physiologic effects of tobacco use. – Sec. 904 of the FDCA

Tobacco industry must disclose information on ingredients and constituents in tobacco products; and must notify FDA of any changes. – Sec. 904 of the FDCA

How FDA oversees the implementation of the Tobacco Control Act

Among other things, FDA:

Established the Center for Tobacco Products to implement the Tobacco Control Act – Sec. 901 of the FDCA

Established the Tobacco Products Scientific Advisory Committee to provide advice, information, and recommendations to the FDA – Sec. 917 of the FDCA

Assesses user fees on tobacco product manufacturers and importers based on their market share. The fees are used to fund FDA activities related to the regulation of tobacco products – Sec. 919 of the FDCA

Reports to Congress on how best to encourage companies to develop innovative products that help people stop smoking.

The Tobacco Control Act preserves the authority of state, local, and tribal governments to regulate tobacco products in certain specific respects. It also prohibits, with certain exceptions, state and local requirements that are different from, or in addition to, requirements under the provisions of the FDCA relating to specified areas.